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@Snowdrop ..... Regarding GET or CBT studies in the pipeline. The SMILE Trial is long finished - that was Esther Crawley's Lightning Process study on youngsters.
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Its Esther Crawley's MAGENTA Trial (Pace for kids) that involves GET.
MAGENTA compares Graded Exercise with Graded Activity.
BMJ Open 4th July 2016
http://bmjopen.bmj.com/content/6/7/e011255
Managed Activity Graded Exercise iN Teenagers and pre-Adolescents (MAGENTA) feasibility randomised controlled trial: study protocol
Abstract
Introduction Paediatric chronic fatigue syndrome or myalgic encephalomyelitis (CFS/ME) is a relatively common and disabling condition, yet there is a limited evidence base for treatment. There is good evidence that graded exercise therapy is moderately effective in adults with CFS/ME, but there is little evidence for the effectiveness, cost-effectiveness, acceptability or best method of delivery for paediatric CFS/ME. This study aims to investigate the acceptability and feasibility of carrying out a multicentre randomised controlled trial investigating the effectiveness of graded exercise therapy compared with activity management for children/teenagers who are mildly or moderately affected with CFS/ME.
Methods and analysis 100 paediatric patients (8–17 years) with CFS/ME will be recruited from 3 specialist UK National Health Service (NHS) CFS/ME services (Bath, Cambridge and Newcastle). Patients will be randomised (1:1) to receive either graded exercise therapy or activity management. Feasibility analysis will include the number of young people eligible, approached and consented to the trial; attrition rate and treatment adherence; questionnaire and accelerometer completion rates. Integrated qualitative methods will ascertain perceptions of feasibility and acceptability of recruitment, randomisation and the interventions. All adverse events will be monitored to assess the safety of the trial.
Ethics and dissemination The trial has received ethical approval from the National Research Ethics Service (South West—Frenchay 15/SW/0124).
Trial registration number ISRCTN23962803; Pre-results.
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The UK ME Children's charity the Tymes Trust wrote to QMUL in February with patient harm concerns about the MAGENTA Trial, and concerns that the Magenta Trial could take place before Independent scientists have had chance to analyse the PACE Trial data.
The Tymes Trust:
https://m.facebook.com/story.php?story_fbid=1711199185831883&id=1482582732026864
Below is the text of a letter we have sent to QMUL which was of course set out on our headed paper.
LETTER TO QMUL
Records and Information Compliance Manager, QMUL
Copy to: Professor Simon Gaskell, Principal, QMUL
RELEASE OF PACE TRIAL DATA
Dear Sir
We understand from your December 2015 statement that you wish to receive patients' views on the release of the PACE trial data.
Tymes Trust is the longest established UK service for children with ME and their families. We are frequently contacted by parents whose children's condition has deteriorated after various regimes of graded exercise, graded activity, and graded school attendance, with its demands upon both body and brain. Therefore we are extremely concerned that, before any fresh analysis of the PACE trial data by independent scientists has taken place, a PACE trial for children (under the appellation MAGENTA) is being set up. This will subject children to graded exercise therapy.
Given the many concerns about the methodology used in the PACE trial, and given the fact that its conclusions are starkly at odds with the findings of patient organisation surveys into graded exercise therapy, which consistently show three quarters of patients reporting deterioration as a result, you must surely agree that parents are entitled to have access to the results of an independent analysis of the PACE trial data before agreeing to subject their children to this therapy.
You may be aware that the published information about the MAGENTA trial confidently states: “There are no risks of participating in the study.” Contrast this with one of the latest patient messages we have received: “Save our children from GET. I know what I am talking about, from an ex triathlete who went from mild to severe ME because of GET.”
We are well aware of the controversy surrounding the release of the PACE trial data, and are amazed that you appear so reluctant to put a speedy end to this potentially damaging and unseemly stand-off between yourselves and a world renowned group of scientists who are only the latest among many to request the release of this data. We hope you will reconsider, rather than fighting the Information Commissioner's order to release the data. It is surely the responsible thing to do.
Yours sincerely
Jane Colby
Executive Director
The Young ME Sufferers Trust
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to do the dirty work for insurance industry. So as much as I'd like to see them punished from the harms they did, it doesn't change status quo and they system behind it. So this will happen again and again. Only at the times some who serve the system will get punished (to please public).
